Commission Implementing Regulation (EU) 2020/1762 of 25 November 2020 concerning the authorisation of a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1762
• Articles: 3

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Minimum content

Maximum content

Other provisions

End of period of authorisation

CFU/kg of complete feedingstuff with a moisture content of 12 %

CFU/l of water for drinking

Category of zootechnical additives. Functional group: gut flora stabilisers

4b1894

Chr. Hansen A/S

Bacillus subtilis DSM 32324 , Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840

Additive composition

Preparation of Bacillus subtilis DSM 32324 , Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 containing a minimum of: 3,2 × 10 9 CFU/g additive (1,6 × 10 9 CFU B. subtilis DSM 32324/g; 1,0 × 10 9 CFU B. subtilis DSM 32325/g and 0,6 × 10 9 CFU B. amyloliquefaciens DSM 25840/g)

All poultry species for fattening or reared for laying or reared for breeding

—

1,6 × 10 9

—

5,4 × 10 8

—

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2.

For use of the additive in water for drinking the homogenous dispersion of the additive shall be ensured.

3.

May be used in feed containing the permitted coccidiostats: diclazuril, decoquinate and halofuginone.

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, glasses and gloves.

16.12.2030

Characterisation of the active substance

Viable spores of cells of Bacillus subtilis DSM 32324 , Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840

Analytical method

( 1 )

Enumeration in the feed additive, premixtures, feedingstuffs and water: Spread plate method on tryptone soya agar (EN 15784).

Identification: Pulsed Field Gel Electrophoresis (PFGE) method.

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports